Delivery system for prosthetic heart valve

ABSTRACT

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/262,110, filed Aug. 30, 2016, which claims the benefit of U.S.Provisional Application No. 62/214,424, filed Sep. 4, 2015. Each of U.S.application Ser. No. 15/262,110 and U.S. Provisional Application No.62/214,424 is incorporated herein by reference in its entirety.

FIELD

The present disclosure concerns embodiments of delivery systems forimplanting prosthetic heart valves.

BACKGROUND

Prosthetic cardiac valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (such as the aortic,pulmonary and mitral valves) serve critical functions in assuring theforward flow of an adequate supply of blood through the cardiovascularsystem. These heart valves can be rendered less effective by congenital,inflammatory or infectious conditions. Such damage to the valves canresult in serious cardiovascular compromise or death. For many years thedefinitive treatment for such disorders was the surgical repair orreplacement of the valve during open heart surgery, but such surgeriesare prone to many complications. More recently, a transvasculartechnique has been developed for introducing and implanting a prostheticheart valve using a flexible catheter in a manner that is less invasivethan open heart surgery.

In this technique, a prosthetic valve is mounted in a crimped state onthe end portion of a flexible catheter and advanced through a bloodvessel of the patient until the prosthetic valve reaches theimplantation site. The prosthetic valve at the catheter tip is thenexpanded to its functional size at the site of the defective nativevalve such as by inflating a balloon on which the prosthetic valve ismounted. Alternatively, the prosthetic valve can have a resilient,self-expanding stent or frame that expands the prosthetic valve to itsfunctional size when it is advanced from a delivery sheath at the distalend of the catheter.

A prosthetic valve that has a relatively large profile or diameter inthe compressed state can inhibit the physician's ability to advance theprosthetic valve through the femoral artery or vein. More particularly,a smaller profile allows for treatment of a wider population ofpatients, with enhanced safety. Thus, a need exists for delivery devicesthat can minimize the overall crimp profile of the prosthetic valve forthe delivery of the prosthetic valve through the patient's vasculature.

Relatively long delivery devices, such as used for transfemoral deliveryof a prosthetic valve, can inhibit the physician's ability to positionthe prosthetic valve precisely at the desired implantation site becausethe forces applied to the handle at one end of the delivery device cancause unwanted movement of the prosthetic valve at the opposite end ofthe delivery device. Thus, a need exists for delivery devices that allowa physician to accurately control the positioning of the prostheticvalve at the desired implantation location.

Known delivery devices typically require a physician to use both handswhen positioning the prosthetic valve at the implantation site.Additionally, in certain circumstances, control mechanisms forpositioning the prosthetic valve can become jammed or kinked duringoperation. Thus, a need exists for delivery devices with improvedcontrol mechanisms for positioning valves.

SUMMARY

Certain embodiments of the disclosure relate to devices and methods forimplanting prosthetic heart valves. In one representative embodiment, adelivery apparatus for implanting a radially compressible and expandableprosthetic heart valve in a native heart valve of the heart comprises ahandle portion and an elongated shaft extending from and movablerelative to the handle portion. The shaft comprises a proximal endportion coupled to the handle portion and a distal end portionconfigured to mount a prosthetic heart valve in a radially compressedstate. The handle portion comprises a control member movablelongitudinally with respect to the handle portion, the control memberengaging a gear assembly operable to convert longitudinal motion of thecontrol member to rotational motion of the gear assembly. The gearassembly engages the elongated shaft such that rotational motion of thegear assembly causes corresponding longitudinal motion of the elongatedshaft relative to the handle portion.

In another representative embodiment, a method of implanting a radiallycompressible and expandable prosthetic heart valve in a native valve ofthe heart comprises introducing a delivery device into the body of apatient, the delivery device comprising a handle portion, an elongatedshaft extending from the handle portion, the shaft having a distal endportion mounting a prosthetic heart valve in a radially compressedstate. The method further comprises advancing the distal end portion ofthe delivery device toward the native heart valve until the prostheticvalve is within or adjacent the aortic arch, wherein the act ofadvancing comprises pushing the handle portion distally so as to pushthe delivery device distally through the patient toward the native heartvalve. The method further comprises steering the delivery device throughthe aortic arch by rotating a rotatable member coupled to the handleportion, rotation of the rotatable member causing corresponding flexingor unflexing of the elongated shaft. The method further comprisesaxially positioning the prosthetic heart valve at a desired implantationposition by moving a lever member coupled to the handle portion, whereinproximal and distal motion of the lever member causes correspondingproximal and distal motion of the elongated shaft relative to the handleportion. The method further comprises radially expanding the prostheticheart valve to engage the annulus of the native heart valve after theprosthetic heart valve has been moved to the desired implantationposition.

In another representative embodiment, a delivery apparatus forimplanting a radially compressible and expandable prosthetic heart valvein a native heart valve of the heart comprises a handle portion, and anelongated balloon catheter shaft extending from the handle portion. Theballoon catheter shaft includes a proximal end portion coupled to thehandle portion and a distal end portion, and further comprises a balloonmounted on the distal end portion and configured to mount a prostheticheart valve in a radially compressed state. The delivery apparatusfurther includes a steerable guide shaft disposed coaxially about theballoon catheter shaft and including a proximal end portion coupled tothe handle portion and a distal end portion. The delivery apparatusfurther includes a positioning assembly including a lever member coupledto the proximal end portion of the balloon catheter shaft such thatlongitudinal motion of the lever member causes correspondinglongitudinal motion of the balloon catheter shaft with respect to theguide shaft and the handle portion. The delivery apparatus furthercomprises a steering assembly including a rotatable member and a pullwire having a proximal end portion operatively connected to therotatable member and a distal end portion fixed to the distal endportion of the guide shaft such that rotation of the rotatable membercauses corresponding flexing and unflexing of the respective distal endportions of the guide shaft and the balloon catheter shaft. Therotatable member of the steering assembly and the lever member of thepositioning assembly are substantially co-located along a longitudinalaxis of the balloon catheter shaft such that the rotatable member andthe lever member are operable with one hand.

The foregoing and other objects, features, and advantages of thedisclosure will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a representative embodiment of a delivery apparatusfor implanting a prosthetic heart valve, according to one embodiment.

FIG. 2 is a cross-sectional view of a handle portion of the deliveryapparatus of FIG. 1.

FIG. 3 is a side elevation view of the handle portion with a portion ofthe shell removed to illustrate the interior of the handle portion.

FIG. 4 is a cross-sectional view of a distal end portion of the deliveryapparatus of FIG. 1.

FIG. 5 is an exploded view of the handle portion of the deliveryapparatus of FIG. 1.

FIG. 6 is an exploded view of a steering assembly of the deliveryapparatus of FIG. 1.

FIG. 7 is an exploded view of an axial position control assembly of thedelivery apparatus of FIG. 1.

FIG. 8 is a perspective view of the handle portion with a portion of theshell removed to illustrate the interior of the handle portion.

FIG. 9 is a cross-sectional side elevation view of a representativeembodiment of a ramp member.

FIG. 10 is a perspective view of a prosthetic heart valve, according toone embodiment.

FIG. 11 is a side elevation view of the prosthetic heart valve of FIG.10.

FIG. 12 is a flow chart illustrating a representative method of using adelivery apparatus.

FIGS. 13-15 illustrate a representative embodiment of a protectivecover.

FIG. 16 is a perspective view of an alternative embodiment of aprotective cover.

FIG. 17 is a perspective view of another embodiment of a rack memberthat can be coupled to a balloon catheter.

FIG. 18 is a cross-sectional view of a portion of the handle of thedelivery apparatus illustrating the rack member and the balloon cathetercoupled to the axial position control assembly.

FIG. 19 is a perspective view of a portion of another embodiment of ashell of a delivery apparatus illustrating a coupling feature.

DETAILED DESCRIPTION

In particular embodiments, a delivery apparatus for implanting aprosthetic, transcatheter heart valve via a patient's vasculatureincludes one or more adjustment devices for adjusting the position of aballoon member including a prosthetic valve radially crimped thereon.The balloon member can be mounted on a distal end of a balloon catheterextending coaxially within a guide (or flex) catheter. As describedbelow in more detail, the balloon member and the crimped prostheticvalve can enter the vasculature of a patient through an introducersheath and, once the balloon member and the crimped prosthetic valvereach a suitable location in the body, the prosthetic valve can beexpanded at the treatment site (e.g., the native aortic valve). The oneor more adjustment devices can further be used to accurately adjust or“fine tune” the position of the prosthetic valve relative to the desireddeployment location.

FIG. 1 shows a delivery apparatus 10 adapted to deliver a prostheticheart valve 12 (e.g., a prosthetic aortic valve) to a heart, accordingto one embodiment. The apparatus 10 generally includes a first elongatedshaft configured as a steerable guide catheter 14, and a secondelongated shaft configured as a balloon catheter 16 extending throughthe guide catheter 14. The guide catheter can also be referred to as aflex catheter or a main catheter. The use of the term main cathetershould be understood, however, to include flex or guide catheters, aswell as other catheters that do not have the ability to flex or guidethrough a patient's vasculature.

The guide catheter 14 and the balloon catheter 16 in the illustratedembodiment are adapted to slide longitudinally relative to each other tofacilitate delivery and positioning of the prosthetic valve 12 at animplantation site in a patient's body, as described in detail below.

The guide catheter 14 includes a handle portion 20 and an elongatedguide tube, or shaft, 22 extending from handle portion 20. FIG. 2 showsthe guide catheter shaft 22 extending from the handle portion 20 overthe balloon catheter 16. The guide catheter 14 can also include asteerable portion generally indicated at 17 (FIG. 1), the curvature ofwhich can be adjusted by the operator to assist in guiding the apparatusthrough the patient's vasculature and, in particular, the aortic arch,as further described below. The steerable portion 17 can be coupled to acontrol device of the handle portion by at least one pull wire 18, suchthat tensioning and releasing the pull wire causes corresponding flexingand unflexing of the steerable section 17 of the guide catheter 14 and,hence, of the balloon catheter 16, as indicated by arrow 41 and furtherdescribed below.

In the illustrated embodiment, the balloon catheter 16 includes aproximal port 24 (FIGS. 2 and 3) adjacent handle portion 20, and anelongated outer balloon catheter shaft 26 that extends from the proximalport 24 and through handle portion 20 and guide tube 22. The handleportion 20 can include a side arm 27 which can be, for example, a flushtube having an internal passage that fluidly communicates with a lumendefined by the handle portion 20. In the illustrated embodiment, theguide tube 22 can terminate at or adjacent a seal member 15 where theflush tube 27 connects with an inner passage defined by the ballooncatheter 16 further described below.

An inflatable balloon 28 can be mounted at the distal end of the ballooncatheter 16. As shown in FIG. 4, the delivery apparatus 10 is configuredto mount the prosthetic valve 12 in a crimped state over the balloon 28for insertion of the delivery apparatus and prosthetic valve into apatient's vasculature.

As shown in FIGS. 2, 3 and 4, the balloon catheter 16 in the illustratedconfiguration further includes an inner balloon catheter shaft 34 thatextends from the proximal port 24 and coaxially through the outerballoon catheter shaft 26 and the balloon 28. The balloon 28 can besupported on a balloon mounting portion 30 disposed on a distal endportion 32 of the outer shaft 26. FIG. 4 illustrates the distal endportion of the delivery apparatus in greater detail. A proximal endportion 36 of the balloon can be folded around a proximal collar member42 (also referred to as a “stop”) of the balloon mounting portion 30mounted on the end of the outer shaft 26 of the balloon catheter and adistal end portion 43 of the balloon 28 can be folded around a distalcollar member 44 of the balloon mounting portion mounted on the distalend portion of the inner shaft 34 of the balloon catheter. In certainembodiments, the distal end of the guide catheter shaft 22 terminatesproximal to the proximal end of the balloon 28. A proximal end portionof the balloon can be secured to the outer balloon catheter shaft 26 orthe guide catheter shaft 22. A distal end portion of the balloon can besecured to a nose cone 31 disposed on or otherwise coupled to the innershaft 34. In some embodiments, after the balloon 28 is folded around theballoon catheter shaft and the collar members 42, 44, the assembly canbe covered by a protective cap or cover 58 (FIG. 1) for storage and/orshipment.

The outer diameter of the inner balloon catheter shaft 34 can be sizedsuch that an annular space 7 is defined between the inner and outerballoon catheter shafts along the entire length of the outer ballooncatheter shaft 26. The proximal port 24 of the balloon catheter 16 canbe formed with a fluid passageway that is fluidly connectable to a fluidsource (e.g., saline) to inflate the balloon and flush the space betweenthe inner and outer balloon catheter shafts. Thus, the fluid passagewaycan be in fluid communication with the annular space 7 between the innerballoon catheter shaft 34 and the outer balloon catheter shaft 26 suchthat fluid from the fluid source can flow through the fluid passageway,through the space between the shafts, and into the balloon 28 to inflatethe same and deploy the prosthetic valve 12. FIG. 4 illustrates the flowof fluid (indicated by arrows 9) through the annular space 7 and throughpassages in the proximal and distal shoulders 42 and 44. The fluid canthen flow into the proximal and distal end portions 36, 43 of theballoon 28 to expand the valve 12.

The inner balloon catheter shaft 34 can also define a lumen 38 (FIG. 2)that is sized to receive a guide wire 29 that can extend coaxiallythrough the inner balloon catheter shaft 34 and optionally through thenose cone 31, as shown in FIG. 4.

The inner balloon catheter shaft 34 and the outer balloon catheter shaft26 of the balloon catheter can be formed from any of various suitablematerials, such as nylon, braided stainless steel wires, or a polyetherblock amide (commercially available as Pebax), to name a few. The shafts26, 34 can have longitudinal sections formed from different materials inorder to vary the flexibility of the shafts along their lengths. Theinner balloon catheter shaft 34 can have an inner liner or layer formedof Teflon® to minimize sliding friction with a guide wire. The shafts26, 34 can also be coaxial about a longitudinal axis 35 (FIG. 2) of theballoon catheter 16, and can be axially movable relative to the handleportion 20 and guide catheter 14 along the axis 35.

The handle 20 in the illustrated embodiment can comprise first andsecond shell portions 50, 52 (FIG. 5) couplable to one another to definean interior cavity 54 (FIGS. 2 and 3). The handle 20 can also include agrip portion 56 engageable by, for example, a user's fingers such thatthe handle can be held with the thumb disposed adjacent a top portion 67of the handle.

As best shown in FIGS. 2 and 3, the handle portion 20 can include anaxial position control assembly 60 and a steering or angular positioncontrol assembly 84 for steering the delivery apparatus through theaortic arch and positioning the balloon and prosthetic valve in theannulus of a native heart valve. The axial position control assembly 60can include an activator or control member configured as a lever member62 coupled to a base member 64 disposed within the handle portion 20adjacent the outer balloon catheter shaft 26. The lever member 62 caninclude a grip portion 66 engageable by a user (e.g., with the thumb),and can be axially movable along a slot 68 defined in the top portion 67of the handle such that axial movement of the lever member causescorresponding axial movement of the base member within the handleportion in the directions indicated by arrow 70.

Referring to FIGS. 5 and 7, a lower surface 72 of the base member 64 caninclude a plurality of teeth or cogs 74 arranged longitudinally along alength of the base member on a side of the base member corresponding tothe second shell portion 52 in the illustrated embodiment. The cogs 74can engage with teeth of a first gear 76 mounted on a shaft 77 of a gearassembly 78 configured as a compound gear extending transverse to theballoon catheter shaft 26 such that axial motion of the base member 64causes corresponding rotational motion of the gear assembly 78. In theillustrated embodiment, the shaft 77 of the gear assembly 78 can extendbeneath the balloon catheter shaft 26, and the gear assembly can furtherinclude a second gear 80 disposed on the shaft 77 on the opposite sideof the balloon catheter shaft 26 from the first gear 76. The teeth ofthe second gear 80 can engage cogs 55 of a rack member 57 coupled to theballoon catheter shaft 26. In this manner, longitudinal motion of thelever member 62 can be converted to rotational motion of the gearassembly 78 by interaction of the base member 64 with the first gear 76,and rotational motion of the second gear 80 can be converted tolongitudinal motion of the balloon catheter shaft 26 in the samedirection as the lever member by interaction of the second gear with therack member 57. Thus, longitudinal motion of the lever member 62 canproduce longitudinal motion of the balloon catheter shaft 26 (and,hence, of the prosthetic valve 12) in the proximal and distal directionsrelative to the handle 20 via rotational motion of the gear assembly 78.

As illustrated in FIG. 7, the first gear 76 can have a diameter D₁ andthe second gear 80 can have a diameter D₂, and the first gear can belarger than the second gear such that the ratio D₂/D₁ defines a gearreduction ratio of the gear assembly 78. Thus, the gear assembly 78 canbe operable such that longitudinal motion of the lever member 62 by agiven distance results in longitudinal motion of the balloon cathetermember 26 that is reduced by a factor corresponding to the gearreduction ratio. For example, in some embodiments, the gear reductionratio can be from about 1.1:1 to about 5:1. In some embodiments, thegear reduction ratio can be from about 1.1:1 to about 3:1. In someembodiments, the gear reduction ratio can be about 2:1. In someembodiments, the gear reduction ratio can be about 1.3:1. In thismanner, the axial position control assembly 60 can provide “fine” axialposition control of the balloon catheter member 26 (and, hence, of theprosthetic valve 12) at the target implantation site after the valve hasbeen advanced to the vicinity of the implantation site. Gear reductionratios such as those given above can also provide mechanical advantageor force amplification of motion inputs to the lever member by a user,allowing the control assembly 60 to be operated with a single thumb orfinger. Owing to the position of the first and second gears 76, 80 onopposite sides of the balloon catheter shaft 26, the gear assembly 78can also be self-centering about the balloon catheter shaft 26 topromote smooth operation and reduce binding.

In the illustrated embodiment, the assembly 60 also includes a lockingmember 81 disposed adjacent the lever member 62 and configured as a leafspring in the illustrated embodiment. In the illustrated embodiment, thelocking member 81 is mounted on the lever member 62 and serves as abiasing member to bias the lever member away from the base member 64.The locking member 81 can include one or more protrusions 82 operable toengage teeth or cogs 83 (FIGS. 2 and 3) located along one or both sidesof the slot 68. In this manner, when the lever member 62 is depressed bya user, the locking member 81 can be elastically deflected inwardlyrelative to the handle such that protrusions 82 disengage from the cogs83, allowing motion of the lever member in the slot. When the levermember 62 is released, the locking member 81 can return to itsnon-deflected state and the protrusions 82 can engage the adjacent cogs83 of the handle portion 20, preventing inadvertent motion of the levermember and, hence, of the balloon catheter shaft 26. In someembodiments, the handle can also include indicator markings or the likeadjacent the slot 68 to indicate a position of the balloon cathetershaft 26 relative to the guide catheter 14.

Referring to FIGS. 5 and 6, the steering assembly 84 can include anactivating member or control member configured as a rotatable member orknob 86 coupled to a threaded shaft 87. The threaded shaft 87 can bedisposed coaxially about the balloon catheter shaft 26 such thatrotation of the rotatable member 86 causes corresponding rotation of thethreaded shaft about the balloon catheter shaft. The assembly 84 canfurther include a pull wire attachment member 85 and a tension member88. The pull wire 18 can be coupled to the attachment member 85, and canextend distally through a pull wire lumen of the shaft 22 of the guidecatheter 14. In the illustrated embodiment, a proximal end portion ofthe pull wire 18 can be fixedly secured to a post 37 of the attachmentmember 85, and a distal end portion of the pull wire 18 can be fixedlysecured at a location along the steerable section 17. In someembodiments, the post 37 can include one or more tie-down members 39about which the pull wire 18 can be wrapped or tied to secure the wireto the post.

The attachment member 85 and the tension member 88 can be movablydisposed on the threaded shaft 87. For example, the attachment member 85and the tension member 88 can include grooves corresponding to thethreads of the threaded shaft 87 such that rotation of the threadedshaft 87 causes longitudinal motion of the attachment member and thetension member along the threaded shaft in the directions indicated byarrow 89 (FIGS. 2 and 3) between a proximal position and a distalposition. In this manner, motion of the attachment member 85 along thethreaded shaft 87 attendant to rotation of the rotatable member 86 canapply or relieve tension in the pull wire 18 cause flexing and unflexingof the steerable section 17. For example, moving the attachment member85 to the proximal end of the threaded shaft 87 corresponds to a fullyflexed position of the guide catheter relative to the longitudinal axis35, and moving the attachment member to the distal end of the threadedshaft corresponds to an unflexed position of the guide catheter relativeto the longitudinal axis 35.

The attachment member 85 and the tension member 88 can also travel alongguide members 47, 49 extending parallel to the threaded shaft 87, asbest shown in FIGS. 2 and 3. In the illustrated embodiment, the guidemembers 47, 49 are tabs extending from the first shell 50 of the handleportion, with the guide member 47 disposed above the threaded shaft 87and the guide member 49 disposed below the threaded shaft. The guidemembers 47, 49 can be received in, for example, corresponding grooves oropenings defined in the attachment member 85 and the tension member 88,respectively, and can reduce or prevent rotation of the attachmentmember and the tension member as they move along the threaded shaft 87.In alternative embodiments, the guide members 47, 49 can extend fromeither the first or second shells 50, 52 of the handle portion 20. Infurther alternative embodiments, the guide members 47, 49 can beconfigured as, for example, rods extending longitudinally parallel tothe threaded shaft 87.

In the illustrated embodiment, the pull wire 18 can enter the handleportion 20 at a location adjacent a tapered section 19 of the guidecatheter. As the pull wire 18 extends proximally from the taperedsection 19 into the handle portion 20, the pull wire can be guided orlifted radially away from the outer diameter of the balloon cathetershaft 26 by a ramp member 90 to a diameter or height h of the tensionmember 88 and/or attachment member 85, and can extend across the tensionmember to the attachment member.

FIG. 9 illustrates the ramp member in greater detail. In the illustratedembodiment, the ramp member 90 can include a distally extendingcylindrical portion 13 and an inclined ramp portion 33. The ramp portion33 can define a channel 11 sized to receive the pull wire 18, and canguide the unconstrained portion of the pull wire exiting the lumen ofthe guide shaft 22 into the handle portion. In the illustratedembodiment, the pull wire 18 can exit the pull wire lumen of the guideshaft 22 distally of the ramp portion 33 and can extend between theguide shaft and the ramp member through a slot or other opening definedin the cylindrical portion 13. By gradually lifting the pull wire 18away from the axis of the pull wire lumen, the channel 11 of the rampmember 90 can reduce the likelihood of the pull wire binding or bucklingwithin the handle portion when, for example, the attachment member 85moves distally along the threaded shaft 87 such that tension in the pullwire is relieved (e.g., attendant to unflexing the steerable section 17of the guide catheter). The ramp member 90 can also include a latchingpawl 25 to engage and couple the ramp member to the handle portion 20.

As illustrated in FIG. 9, the ramp member 90 can also define a lumen 21extending the length of the member and configured to receive the guideshaft 22. A proximal portion of the lumen 21 can be tapered such thatthe walls of the lumen engage and retain the guide shaft 22, while adistal portion of the lumen has a diameter greater than the diameter ofthe guide shaft and does not contact the guide shaft when it is in anon-deflected state. In some embodiments, an adhesive can be applied atleast to the tapered portion of the lumen 21 to aid in retaining theguide shaft 22. In this manner, the ramp member 90 can provide strainrelief for the guide shaft 22 as it is flexed, helping to reduce orprevent buckling of the guide shaft within the handle portion 20 whenthe guide shaft is flexed.

The tension member 88 can be disposed on the threaded shaft 87 adjacentthe attachment member 85 and, in some embodiments, coupled to theattachment member, such that the tension member and the attachmentmember move together along the threaded shaft. As the attachment member85 moves proximally along the threaded shaft 87 by rotation of therotatable member 86 (corresponding to flexing of the guide catheter),the tension member 88 can prevent the attachment member from movingdistally along the threaded shaft when manual pressure is released fromthe rotatable member. For example, a user can rotate the rotatablemember 86 until a selected degree of flexion of the guide catheter isachieved (e.g., corresponding to a desired angle of the prosthetic valverelative to the native heart valve at the implantation site). When theuser releases the rotatable member 86, the tension member 88 can retainthe attachment member 85 at the position on the threaded shaft 87corresponding to the selected degree of flexion so that the guidecatheter does not inadvertently unflex (owing to, for example, a threadpitch that provides sufficient friction to prevent movement of thetension member without force application by a user).

Thus, by keeping the attachment member 85 at the selected position onthe threaded shaft 87, the tension member 88 maintains tension in thepull wire 18 when the guide catheter is flexed. The tension member 88,in combination with channel 11 of the ramp member 90, can also reduce orprevent kinking of the pull wire 18 inside the handle portion 20 whenthe guide catheter is unflexed by guiding the pull wire into the lumenof the guide catheter, and by allowing any extra length of the pull wireto remain in a slackened state within the handle portion. This can beespecially advantageous when the guide catheter is unflexed in a curvedor constrained anatomy (for example, the aortic arch), in which theguide catheter cannot fully straighten.

The steering assembly 84 can also include a visual indicator 91 coupledto, for example, the tension member 88, and configured to moveproximally and distally therewith in a window or slot 92 defined in thedistal portion 46 of the handle 20. In this manner, the indicator 91 canindicate a degree of flexion of the guide catheter to a user based uponthe location of the tension member 88 within the handle portion 20. Inthe illustrated embodiment, the slot 92 can be inclined in a generallyproximal direction according to the shape of the distal handle portion20.

As best shown in FIG. 6, the visual indicator 91 can define an opening61 to receive a projection or post 63 extending from the tension member88. In this manner, the post 63 can move the visual indicator 91proximally and distally in the slot 92 as the tension member 88 movesalong the threaded shaft 87. The visual indicator 91 can also include anarm or tab 65 (FIG. 8) extending orthogonally to the post 63 andconfigured to engage an extension portion 71 located below the slot 92.In this manner, as the visual indicator 91 moves proximally along theinclined extension portion 71 of the slot, the visual indicator can belifted relative to the tension member 88 by the tab 65. Conversely, asthe visual indicator 91 moves distally along the extension portion 71,the visual indicator can be lowered relative to the tension member. Theindicator therefore moves along an inclined path parallel to the slot92. Motion of the visual indicator 91 relative to the tension member 88as the tension member and visual indicator move proximally and distallyis illustrated by double-headed arrow 73 (FIGS. 2 and 3). In thismanner, the visual indicator 91 can remain visible to a user along thelength of the slot 92. In some embodiments, the slot 92 can be coveredby a transparent cover to protect the visual indicator 91 and toprevent, for example, a user's finger, from interfering with motion ofthe visual indicator.

The rotatable member 86 can be accessible through an opening 51 definedon a side portion of the first shell 50 and/or an opening 53 defined ina side portion of the second shell 52, as shown in FIG. 5. This canallow the rotatable member to be operated by the thumb, finger(s), or acombination thereof, of one hand. In the illustrated embodiment, therotatable member 86 can be located below and adjacent the lever member62. Additionally, the rotatable member 86 and at least the grip portion66 of the lever member 62 can be substantially co-located along thelongitudinal axis 35 of the balloon catheter 16. More specifically, therotatable member 86 can be located such that a mid-sectional axis 23(FIG. 1) of the rotatable member passes through or near the center ofthe slot 68. This can facilitate one-handed operation of the levermember and/or the rotatable member regardless of the position of thelever member in the slot without requiring the user to reposition theirhand during use.

FIGS. 10 and 11 show a prosthetic heart valve 100, according to oneembodiment, that can be used with the delivery apparatus 10. Theprosthetic heart valve 100 comprises a frame, or stent, 102 and aleaflet structure 104 supported by the frame. In particular embodiments,the heart valve 100 is adapted to be implanted in the native aorticvalve and can be implanted in the body using, for example, the deliveryapparatus 10 described above. The prosthetic valve 100 can also beimplanted within the body using any of the other delivery apparatusesdescribed herein. Thus, the frame 102 typically comprises a plasticallyexpandable material, such as stainless steel, a nickel based alloy(e.g., a nickel-cobalt-chromium alloy), polymers, or combinationsthereof. In other embodiments, the prosthetic valve 100 can be aself-expandable prosthetic valve with a frame made from a self-expandingmaterial, such as Nitinol. When the prosthetic valve is a self-expandingvalve, the balloon of the delivery apparatus can be replaced with asheath or similar restraining device that retains the prosthetic valvein a radially compressed state for delivery through the body. When theprosthetic valve is at the implantation location, the prosthetic valvecan be released from the sheath, and therefore allowed to expand to itsfunctional size. It should be noted that any of the delivery apparatusesdisclosed herein can be adapted for use with a self-expanding valve.

With reference to FIG. 12, a representative method of implanting aprosthetic heart valve using the delivery devices disclosed herein canproceed in the following manner. At block 202, a delivery device can beintroduced into the body of a patient via, for example, an incision inthe femoral artery. The delivery device can comprise a handle portionand an elongated shaft extending from the handle portion. The shaft canhave a distal end portion mounting a prosthetic heart valve in aradially compressed state.

At block 204, the distal end portion of the delivery device can beadvanced toward the native heart valve until the prosthetic valve iswithin or adjacent the aortic arch, wherein the act of advancingcomprises pushing the handle portion distally so as to push the deliverydevice distally through the patient toward the native heart valve.

At block 206, the device can be steered through the aortic arch byrotating a rotatable member coupled to the handle portion, whereinrotation of the rotatable member causes corresponding flexing orunflexing of the elongated shaft.

At block 208, the prosthetic heart valve can be axially positioned at adesired implantation position by moving a lever member coupled to thehandle portion. Proximal and distal motion of the lever member can causecorresponding proximal and distal motion of the elongated shaft relativeto the handle portion. In some embodiments, the prosthetic heart valvecan be angularly positioned at a desired implantation angle by rotatingthe rotatable member coupled to the handle portion (e.g., at or near theaortic root) before, concurrently with, or after the prosthetic heartvalve is axially positioned.

At block 210, after the prosthetic heart valve has been moved to thedesired implantation position, the prosthetic heart valve can bedeployed (e.g., radially expanded) to engage the annulus of the nativeheart valve.

Although the disclosed embodiments pertain generally to delivery devicesand methods for implantation of prosthetic heart valves in the nativeaortic valve, it should be understood that the disclosed embodiments canbe used to implant prosthetic devices at any location of the heart orelsewhere in the body. Additionally, although the disclosed embodimentspertain generally to transfemoral delivery of prosthetic devices, itshould be understood that the disclosed embodiments can be adapted foruse with, for example, transapical procedures, transaortic procedures,trans-subclavian procedures, transradial procedures, or trans-septalprocedures. For example, the embodiments disclosed herein can be adaptedfor use with delivery devices for implanting self-expandable prostheticvalves, in which the axial position control assembly 60 and the angularposition control assembly 84 can be coupled to an elongated guidecatheter or shaft since a balloon catheter is not required.

FIGS. 13-15 illustrate a representative embodiment of the protectivecover 58 in greater detail. In the illustrated embodiment, theprotective cover 58 can have a clam shell configuration and can comprisecomplementary first and second cover portions 45, 59 (see FIGS. 13 and14) that encapsulate the balloon and, in certain configurations, aportion of the balloon catheter shaft 26.

FIG. 13 illustrates a representative embodiment of the first coverportion 45 including a proximal end portion 69, an intermediate portion75, and a distal end portion 79. The first cover portion 45 can define arecess 93 extending from the proximal end portion 69, through theintermediate portion 75 to the distal end portion 79, and being shapedto substantially match the shape of the balloon 28 when it is foldedaround the proximal and distal collars 42, 44 (see FIG. 4). For example,the recess 93 can define a proximal collar-receiving portion 94 toreceive the proximal collar 42, a distal collar-receiving portion 95 toreceive the distal collar 44, and a central portion 96 to receive theinner shaft 34. FIG. 14 illustrates the balloon mounting portion 30 ofthe delivery device situated in the recess 93 such that the proximal anddistal collars 42, 44 are received in the respective collar-receivingportions 94, 95, and the inner shaft 34 is received in the centralportion 96.

The second cover portion 59 can define a complementary recess such thatwhen the first and second cover portions are assembled together, thecover 58 defines a cavity shaped to accommodate the folded balloon 28and the catheter assembly. The assembled cover portions 45, 59 can thenbe inserted inside a sheath or sleeve 97, which can keep the coverportions from separating, as illustrated in FIG. 15. In the illustratedembodiment, the first and second cover portions can also include ribmembers 98 extending along, for example, the intermediate portion 75, toprovide strength and rigidity to the cover.

When situated inside the cover 58, the balloon 28 can be prevented fromexpanding substantially or otherwise deviating from its folded shape.Thus, after the balloon 28 is folded around the proximal and distalcollars 42, 44, the balloon mounting portion 30 can be placed in thefirst and second cover portions 45, 59, and the sleeve 97 can be placedover the cover portions to form the assembled cover 58. The cover 58 canthereby protect the balloon from scratches, tears, etc., during assemblyand shipping of the delivery device. Additionally, because the balloon28 cannot substantially deviate from its folded shape when received inthe cover 58, the cover can also facilitate pressure and/or vacuumtesting of the balloon after assembly and/or in the operating theater.More specifically, the balloon 28 can be tested in the cover 58 byintroduction of gas, fluid, or vacuum at the assembly location, and/orin the operating room prior to crimping of the valve 12, because theballoon is held in its folded configuration by the contoured cavity ofthe cover. Therefore, the physician does not need to perform any foldingsteps after balloon testing and prior to crimping the valve 12 on theballoon.

FIG. 16 illustrates an alternative embodiment of a first cover portion300 including a plurality of projections 302 located along a matingsurface 304 of the cover portion. In certain configurations, acomplementary second cover portion can define corresponding openings toreceive the projections 302 to aid in retaining the first and secondcover portions in an assembled state.

FIGS. 17 and 18 illustrate another embodiment of a rack member 400similar to the rack member 57 of the embodiment of FIG. 1. The rackmember 400 can include a main body portion 402 including gear teeth orcogs 404 extending along at least a portion of the length of the mainbody. The rack member 400 can also include a cradle 406 positioned on aside of the main body 402 and configured to receive the balloon cathetershaft 26. For example, in the illustrated embodiment, a collar member408 can be disposed about the balloon catheter shaft 26. The cradle 406can be adapted to engage the collar member 408 (e.g., by snap-fitting)such that the collar member is received in the cradle. Curved armportions 410 at either end of the cradle 406 can limit axial movement ofthe collar member 408 and, hence, of the balloon catheter shaft 26,relative to the main body 402 of the rack member. This configurationallows the collar member 408 to be coupled to the balloon catheter shaft26 (e.g., by adhesive bonding and/or fasteners) at a desired positionalong the length of the balloon catheter shaft before final assembly ofthe delivery device. The balloon catheter-collar member assembly canthen be easily coupled to the rack member 400. FIG. 18 is across-sectional view of the rack member 400 and the collar member 408coupled to the balloon catheter shaft 26 and engaged with the axialposition control assembly 60 within the second shell portion 52.

FIG. 19 is a cross-sectional view of a portion of another embodiment ofthe second shell portion 52 illustrating a coupling mechanism 502. Thecoupling mechanism 502 is located at the proximal end of the guidemembers 47, 49, and can include a base portion 504 and arms 506, 508extending from the base portion. The coupling mechanism 502 can beconfigured to receive the threaded shaft 87 such that the arms 506, 508engage the threaded shaft and prevent longitudinal movement of thethreaded shaft during assembly and use of the device. For example, withreference to FIG. 8, the arms 506, 508 can be configured to engage thethreaded shaft 87 at a recess 510 defined between first and secondcollar portions 512, 514 of the threaded shaft 87. By locating the arms506, 508 between the collar portions 512, 514, the arms can preventundesirable longitudinal movement of the threaded shaft 87, whileallowing the threaded shaft to rotate to flex and unflex the guidecatheter 14.

General Considerations

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallymay in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods. Additionally, the description sometimes uses terms like“provide” or “achieve” to describe the disclosed methods. These termsare high-level abstractions of the actual operations that are performed.The actual operations that correspond to these terms may vary dependingon the particular implementation and are readily discernible by one ofordinary skill in the art.

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Further, the terms “coupled” and “associated” generally meanelectrically, electromagnetically, and/or physically (e.g., mechanicallyor chemically) coupled or linked and does not exclude the presence ofintermediate elements between the coupled or associated items absentspecific contrary language.

In the context of the present application, the terms “lower” and “upper”are used interchangeably with the terms “inflow” and “outflow”,respectively. Thus, for example, the lower end of the valve is itsinflow end and the upper end of the valve is its outflow end.

As used herein, the term “proximal” refers to a position, direction, orportion of a device that is closer to the user and further away from theimplantation site. As used herein, the term “distal” refers to aposition, direction, or portion of a device that is further away fromthe user and closer to the implantation site. Thus, for example,proximal motion of a device is motion of the device toward the user,while distal motion of the device is motion of the device away from theuser. The terms “longitudinal” and “axial” refer to an axis extending inthe proximal and distal directions, unless otherwise expressly defined.

In view of the many possible embodiments to which the principles of thedisclosure may be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather, the scope of thedisclosure is defined by the following claims.

1. A delivery apparatus for implanting a radially compressible andexpandable prosthetic heart valve in a native heart valve of the heart,the apparatus comprising: a handle portion; an elongated shaft extendingfrom and movable relative to the handle portion, the shaft comprising aproximal end portion coupled to the handle portion and a distal endportion configured to mount a prosthetic heart valve in a radiallycompressed state; the handle portion comprising a control member movablelongitudinally with respect to the handle portion to effect longitudinalmotion of the elongated shaft relative to the handle portion, thecontrol member having a grip portion; the handle portion furthercomprising a rotatable member coupled to the handle portion, therotatable member being configured to adjust a curvature of the elongatedshaft; wherein the grip portion of the control member is movabledistally and proximally of the rotatable member by longitudinal motionof the control member.
 2. The delivery apparatus of claim 1, wherein thecontrol member comprises a base member disposed within the handleportion and coupled to the elongated shaft, and a lever member extendingfrom the base member out of the handle portion, the grip portion being apart of the lever member.
 3. The delivery apparatus of claim 2, wherein:the handle portion defines a longitudinally extending slot; and thelever member of the control member is movable within the slot.
 4. Thedelivery apparatus of claim 3, wherein the lever member of the controlmember further comprises a biasing member configured to bias the levermember away from the handle portion.
 5. The delivery apparatus of claim4, wherein the biasing member comprises a protrusion configured toengage teeth located along the slot of the handle portion.
 6. Thedelivery apparatus of claim 1, wherein: the rotatable member is hollow;and at least a portion of the control member is movable into and out ofthe rotatable member.
 7. The delivery apparatus of claim 6, wherein thecontrol member comprises a base member disposed within the handleportion and a lever member extending from the base member out of thehandle portion, and the base member is movable into and out of therotatable member.
 8. The delivery apparatus of claim 1, wherein thecontrol member engages a gear assembly operable to convert longitudinalmotion of the control member to rotational motion of the gear assembly,the gear assembly engaging the elongated shaft such that rotationalmotion of the gear assembly causes longitudinal motion of the elongatedshaft.
 9. The delivery apparatus of claim 8, wherein the grip portion ofthe control member is proximal of the gear assembly.
 10. The deliveryapparatus of claim 8, wherein the gear assembly is a compound gearincluding a first gear operatively connected to the control member and asecond gear operatively connected to the elongated shaft.
 11. Thedelivery apparatus of claim 10, wherein the first and second gears aresituated on opposite sides of the elongated shaft and coupled to a gearshaft extending transverse to the elongated shaft.
 12. The deliveryapparatus of claim 11, wherein the gear assembly further comprises: afirst rack gear member coupled to the control member and comprising aplurality of teeth configured to engage the first gear; and a secondrack gear member coupled to the elongated shaft on the opposite side ofthe elongated shaft from the first rack gear member, the second rackgear member comprising a plurality of teeth configured to engage thesecond gear.
 13. The delivery apparatus of claim 1, wherein: theelongated shaft is a balloon catheter shaft; the delivery apparatusfurther comprises a steerable guide shaft disposed coaxially about theballoon catheter shaft; and the rotatable member is coupled to aproximal end portion of the steerable guide shaft by a pull wire suchthat rotation of the rotatable member adjusts a curvature of a distalend portion of the steerable guide shaft.
 14. A method of using thedelivery apparatus of claim 1, comprising: introducing the deliveryapparatus into the body of a patient, the distal end portion of theelongated shaft comprising a prosthetic heart valve mounted thereon in aradially compressed state; advancing the distal end portion of theelongated shaft toward a native heart valve of the patient until theprosthetic heart valve is within or adjacent the aortic arch, whereinthe act of advancing comprises pushing the handle portion distally so asto push the delivery apparatus distally through the patient toward thenative heart valve; steering the delivery apparatus through the aorticarch by rotating the rotatable member to adjust of a curvature of theelongated shaft; axially positioning the prosthetic heart valve at adesired implantation position by axially moving the grip portion of thelever member; and radially expanding the prosthetic heart valve toengage the annulus of the native heart valve.
 15. A delivery apparatusfor implanting a radially compressible and expandable prosthetic heartvalve in a native heart valve of the heart, the apparatus comprising: ahandle portion; an elongated shaft extending from and movable relativeto the handle portion, the shaft comprising a proximal end portioncoupled to the handle portion and a distal end portion configured tomount a prosthetic heart valve in a radially compressed state; thehandle portion comprising a control member movable longitudinally withrespect to the handle portion to effect corresponding longitudinalmotion of the elongated shaft relative to the handle portion; the handleportion further comprising a rotatable member coupled to the handleportion, the rotatable member being configured to adjust a curvature ofthe elongated shaft; wherein the control member is positionable over therotatable member so that the control member and the rotatable member areoperable with one hand.
 16. The delivery apparatus of claim 15, whereinthe control member comprises a grip portion, and the grip portion ispositionable over the rotatable member.
 17. The delivery apparatus ofclaim 16, wherein the control member comprises a base member disposedwithin the handle portion and coupled to the elongated shaft, and alever member extending from the base member out of the handle portion,the grip portion being a part of the lever member.
 18. The deliveryapparatus of claim 15, wherein the control member is movable in a slotdefined in the handle portion, and the control member includes a lockingmember operable to engage and disengage one or more cogs disposed alongthe slot when the control member is released and depressed,respectively, relative to the handle portion.
 19. The delivery apparatusof claim 18, wherein the locking member comprises a biasing memberconfigured to bias the control member away from the handle portion. 20.A delivery apparatus for implanting a radially compressible andexpandable prosthetic heart valve in a native heart valve of the heart,the apparatus comprising: a handle portion; an elongated ballooncatheter shaft extending from the handle portion, the balloon cathetershaft including a proximal end portion coupled to the handle portion anda distal end portion, the balloon catheter shaft further comprising aballoon mounted on the distal end portion and configured to mount aprosthetic heart valve in a radially compressed state; a steerable guideshaft disposed coaxially about the balloon catheter shaft and includinga proximal end portion coupled to the handle portion and a distal endportion; an axial positioning assembly including a lever member coupledto the proximal end portion of the balloon catheter shaft and movablelongitudinally with respect to the handle portion such that longitudinalmotion of the lever member causes longitudinal motion of the ballooncatheter shaft with respect to the guide shaft and the handle portion; asteering assembly including a rotatable member and a pull wire having aproximal end portion operatively connected to the rotatable member and adistal end portion fixed to the distal end portion of the guide shaftsuch that rotation of the rotatable member adjusts curvatures of therespective distal end portions of the guide shaft and the ballooncatheter shaft; wherein the lever member is positionable over therotatable member along the handle portion.